FDA Adverse Event
Injury
Summary report: N
UNKNOWN SUTURE PRODUCT
MDR report key: 3072969
·
Received April 23, 2013
Report
- Report Number
- 2210968-2013-04315
- Event Type
- Injury
- Date Received
- April 23, 2013
- Date of Event
- March 28, 2013
- Report Date
- April 2, 2013
- Manufacturer
- ETHICON, INC SOMERVILLE
- Product Code
- GAM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED TO CLOSE THE ABDOMEN. THE PATIENT EXPERIENCED A WOUND DEHISCENCE AND REQUIRED A REOPERATION TO CLOSE THE WOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173399 | UNKNOWN SUTURE PRODUCT | SUTURE | GAM | ETHICON, INC SOMERVILLE | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |